【摘要】 目的考察国产琥乙红霉素原料和制剂的组分和有关物质,为修订中国药典2005年版琥乙红霉素质量标准提供依据。方法采用美国药典30版收载的HPLC法测定6个厂家的红霉素原料、琥乙红霉素原料和制剂共16批样品的组分和有关物质,并采用欧洲药典5.0版收载的方法测定琥乙红霉素样品中游离红霉素的含量。结果国产红霉素以红霉素A为主组分,含有少量的红霉素B、红霉素C和红霉素E组分,有关物质主要为脱水红霉素A,其它有关物质含量较少。以红霉素为原料合成的琥乙红霉素中的主要有关物质为游离红霉素。结论建议将中国药典2005版琥乙红霉素有关物质的薄层色谱法修订为高效液相色谱法,便于更好地控制产品质量。更多还原

【Abstract】 Objective To investigate the related substances profiles of the domestic erythromycin ethylsuccinate bulk material and preparation,and provide data for the monograph of erythromycin ethylsuccinate in the Chinese Pharmacopoeia 2005.Method The ingredient and the related substances of totally 16 batches of erythromycin ethylsuccinate bulk material and preparation of 6 manufacturers were determined using the HPLC method of USP 30,and the erythromycin free base were determined using the method of EP 5.0.Results The major ingredient of domestic erythromycin was erythromycin A and there were minor amount of erythromycin B,C and E.The main related substances was anhydro-erythromycin A and the content of other impurities were relatively small.The major related substances of erythromycin ethylsuccinate synthesized by using erythromycin as starting material was erythromycin free base.Conclusion To ensure better quality control for the products,it is recommended that the TLC method involved in the Chinese Pharmacopoeia 2005 to determine the related substances of erythromycin ethylsuccinate to be replaced by the HPLC method.更多还原